Wednesday, September 15, 2004

"Foot-dragging and alibis"*: the FDA and antidepressant prescription for kids

This hasn't been my major focus, by all means, but I have been following with great interest and curiousity the pediatric anti-depressant story throughout the year.

Recent media coverage has been horribly superficial, in my opinion, despite the seemingly strong headlines:
WaPo"FDA Panel Urges Stronger Warning..." by Lauren Neergaard
NYT "Panel Urges Strong Warning..." by Gardiner Harris
LA T (actually this one was better but read it ASAP since it'll soon be locked up)"Suicide Risk to Children Affirmed" by Elizabeth Shogren
Okay. Obviously, we've now got recommendations for strong warning labels. But what bothers me to no end is there's a bit more to the story than what has been reported by (corporate) media. Fortunately for all of us, you can glean some of that info, if you have the time, if you view the House sub-committee hearings on CSPAN. Thank goodness for CSPAN.

And so let it be known I've been using my precious online time to actually listen to this CSPAN online video instead of blogging. What an eye opener. I was seriously impressed with the work of our politicians, even by the Republicans, and especially Joe Barton, from Texas. Which leads me to suggest, if you have kneejerk negative reactions to Republicans as I do most of the time, please, watch 6 minutes of this online video, with an open mind. You might add shades of grey to your opinions about Republicans, especially Texas Republicans because these committee members were doing what they are supposed to be doing: protecting public interest. Heroes, in my book.

And if you do this, you might be surprised to find that the media articles in general have either buried stuff way in the back of the article or seriously omitted helpful information that would put the whole thing in amazing perspective. The reason why this is eludes me although I suspect it might be just plain laziness. In any case, I think the information not included paint the FDA even more heinous than you could tell from just reading the newspaper.

Helpful information:
1. FDA gave pharm companies a 6 month of extension on their drug patents so that they could complete more drug studies to determine how effective the drugs were. This means 6 more months of profit or 6 more months of extra money. Notice: not much in the media about this. And what did the FDA do doing this time? Continue on.

2. During this 6 month period, the FDA rebuffed repeatedly requests from the House sub-committee to provide more info on their internal drug studies. It turns out 12 out of 15 studies showed no efficacy but the FDA has been consistently refusing to release data from these trials, to anyone outside of the agency even to the oversight committee. In fact, on day one of the hearings, Joe Barton threatened to send police to the FDA offices to ensure they would comply with their request to provide all of their info on these studies. The FDA official present, with quivering lips, agreed to provide the memos and information, looking just about ready to fall apart. Hello, media, where were you on this? I didn't read anything about the FDA stone-walling the sub-committee in this manner.

3. I thought that the major result of the drug studies was that there was no efficacy in children. This important point was not emphasized in the media.

4. Instead, the media jumped all over the increased suicidal ideation stuff: symptoms increased in 2-3% of the population. But the media did not discuss specifics: that this meant in the last internal study of 4250 kids, 400 kids experienced symptoms. This is not trivial when there is no efficacy (see point 3 above). And note, I read a piece by someone on NRO arguing this was no big deal, no one died but I strongly differ with that opinion. More kids having symptoms is not okay, especially when these are symptoms related to suicidal thoughts.

5. I thought it is important to note that England decided to completely ban use of Paxil in the pediatric population. This was one of the reasons why we had this whole hearing in the US.

6. No mention of how the FDA prevented one of their researchers from presenting his results in April at one of these public hearings.
Dr. Andrew D. Mosholder, an agency epidemiologist, was the man charged with analyzing 22 studies involving 4,250 children and seven drugs. In a carefully argued, 33-page memorandum, he concluded that children given antidepressants were almost twice as likely as those given placebos to become suicidal.

He urged the agency to discourage doctors from prescribing to children all antidepressants except Prozac. Prozac is the only antidepressant proven effective in treating depressed children, and its studies showed no link with suicide, Dr. Mosholder wrote. Dr. Mosholder's conclusions mirrored those made by British health authorities.
7. Interesting that Prozac is the only anti-depressant shown to have (dubious) efficacy, yet in the US, other anti-depressants are prescribed more by physicians for kids. Henry Waxman brought up this excellant point. Uh, why is that the case? Could it be...sales reps pushing a biased array of drug studies?

8. Finally, stronger warning labels is a good start. But I want to see more: more education of GP's who prescribe this stuff to kids, more information out to GP's as well as to the general public, more transparency on the part of the FDA. And what about banning Paxil for kids?

I admit this post is not the end-all be-all analysis of the whole thing. I do hope someone will continue with this story and expand upon it. And if I'm wrong, then I hope someone can clarify some of the issues brought up here.

*I'll end with Joe Barton, who said it best: "...the Food and Drug Administration really stands for foot-dragging and alibis".